K172702

Substantially Equivalent

Tec 820, Tec 850

Applicant: Datex-Ohmeda, Inc.
Product code: CAD
Advisory panel: Anesthesiology
Date received: 2017-09-07
Decision date: 2018-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

Adverse events under product code CAD

product code CAD

Malfunction: 3,275
Total: 3,275

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.